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The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, fibula, metacarpals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDAcleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.

The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light fiber that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, fibula, and anterior ring of the pelvis. The purpose of this Special 510(k) is to expand the indications of the IlluminOss Photodynamic Bone Stabilization System (PBSS) to include use in the femur and tibia in conjunction with FDA-cleared fracture fixation systems.

The provided text describes the IlluminOss Photodynamic Bone Stabilization System (PBSS) and its expanded indications for use. However, it does not contain the specific details about acceptance criteria, a comparative study with a test set, ground truth establishment, or human reader performance that would typically be found in a detailed study report.

Based on the information provided in the 510(k) summary:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Improves pull-out strength	Device demonstrated statistically significantly higher screw pull-out loads compared to when the IlluminOss device is not used.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   The document does not specify the sample size for the test set or data provenance (country of origin, retrospective/prospective). It generally refers to "samples" being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
   A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, as this device is a physical medical device (bone stabilization system), not an AI algorithm for diagnostic imaging.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   This question is not applicable as the device is a physical bone stabilization system, not an algorithm. However, performance testing of the device itself (standalone) was conducted, focusing on its mechanical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   The "ground truth" in this context is likely derived from mechanical testing data (e.g., direct measurements of pull-out strength in a laboratory setting) rather than clinical expert consensus or pathology, as the study focuses on the device's mechanical performance in supplemental fixation.

8. The sample size for the training set
   This information is not provided. It's important to note that for a physical device undergoing mechanical testing, the concept of a "training set" as understood in machine learning is generally not applicable. Instead, there would be samples used for initial design verification and validation testing.

9. How the ground truth for the training set was established
   Not applicable, as a "training set" in the machine learning sense is not relevant here. For the mechanical testing performed, the "ground truth" (i.e., the actual pull-out strength for a given construct) would have been established through direct experimental measurement in a controlled laboratory environment.

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The aap LOQTEQ® Distal Medial Tibia Plate 3.5 System is intended for

• Fixation of complex intra- and extra- articular fractures of the distal tibia
• Osteotomies of the distal tibia

Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator (internal fixation) will be realized.

The LOQTEQ® Distal Medial Tibia Plate 3.5 System consists of:
• LOQTEQ® Distal Medial Tibia Plate 3.5, left and right version
• LOQTEQ® Cortical Screws 3.5, self-tapping (locking bone screw)
• LOQTEQ® Cortical Screws 3.5 small head, self-tapping (locking bone screw)
• Cortical Screws 3.5, self-tapping
• Cortical Screws 3.5 small head, self tapping
• Instruments, Distal Medial Tibia Plate 3.5

The provided text describes a medical device, the "aap LOQTEQ® Distal Medial Tibia Plate 3.5 System," and its non-clinical performance evaluation, specifically focusing on mechanical testing for substantial equivalence.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document only states "Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use." It does not specify:

• The exact sample size for the mechanical tests.
• The data provenance (e.g., country of origin, retrospective or prospective). Mechanical tests are typically performed in a lab setting, so "provenance" in the context of patient data is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" for mechanical testing is typically established by engineering standards and test protocols, not by expert medical consensus in the same way as, for example, image interpretation.

4. Adjudication method for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation or clinical endpoints, not typically for mechanical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This document describes the mechanical testing of a bone plate system, not an AI-powered diagnostic device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a medical implant (bone plate system), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data (mechanical tests), the "ground truth" is established by engineering standards and established biomechanical principles for measuring strength, fatigue life, and other mechanical properties under simulated physiological conditions. The document refers to "pre-defined acceptance criteria," which would stem from these engineering standards and comparison to the predicate device.

8. The sample size for the training set

This information is not provided and is not applicable to this type of device (mechanical implant). The concept of a "training set" is relevant for machine learning algorithms, not for the mechanical testing described.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as there is no "training set" in the context of this device's evaluation.

In summary: The provided document is a 510(k) summary for a medical implant, focusing on demonstrating substantial equivalence to a predicate device primarily through non-clinical mechanical testing. It does not involve AI, human readers, or clinical trials with patient-specific ground truth in the way a diagnostic AI device would. Therefore, many of your questions are not relevant or addressed by this type of submission.

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The OrthoPediatrics PediPlate™ system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.

Specific pediatric conditions/diseases for which the devices will be indicated include:

• Valgus, varus, or flexion, extension deformities of the knee (femur and/or tibia) .
• Valgus, varus, or plantar flexion deformities of the ankle
• Valgus or varus deformities of the elbow (humerus)
• Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. There is an alignment mark or small provisional fixation hole in the center of the O. H and I-Plates to aid accurate placement of the device relative to the growth plate that is localized radiographically. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is transfixed to bone using two to four screws, depending on which plate is selected.

• Materials: The devices are manufactured from 316L stainless steel, which meet ASTM F138 or ASTM F139.
• Function: The system functions to provide immediate stability and temporary . fixation during the natural healing process.
  The OrthoPediatrics PediPlate TM System is intended for use in the treatment of pelvic, small and long bone fractures, as well as deformity corrections of pediatric patients' long bones, which includes osteotomies, and redirecting the angle of growth of children's long bones. The system includes cortical and cannulated screws, and specialty plates, referred to as O, 1, and H-Plates.

Based on the provided document, I cannot fulfill the request because the document is a 510(k) summary for the OrthoPediatrics PediPlates™ System, which is a medical device for bone fixation. This type of document establishes substantial equivalence to predicate devices and outlines the device description, indications for use, and materials.

However, it does not contain the information required to describe acceptance criteria and a study proving device performance against those criteria. Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study proving performance, sample sizes (test set, training set), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document focuses on:

• Establishing substantial equivalence to predicate devices (K081407, K073344, K031493, K020221, K993106, K000684, K013248, K080522).
• Describing the device's design, materials (316L stainless steel), and function (immediate stability and temporary fixation during healing).
• Listing the indications for use for adult and pediatric patients for various bone fracture fixations and deformity corrections.

Therefore, since the document discusses a physical medical device (bone plates for fixation) and not an AI/software device, and lacks any clinical study data or performance metrics against specific acceptance criteria, I cannot extract the information requested related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device evaluation.

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The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.

Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.

The system is not intended for spinal use.

The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile left and right titanium plate in three lengths with various length cortical and/or cancellous locking self-tapping stabilization screws. The fibula plate is made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a medical device, the I.T.S. Fibula Plate PROlock with Angular Stability, and its 510(k) summary for clearance by the FDA. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary focuses on establishing substantial equivalence to predicate devices, not on demonstrating specific performance metrics against defined acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or an MRMC study based on the provided text.

Here's why and what information is present:

• Acceptance Criteria and Reported Device Performance: This information is completely absent. The document is about regulatory clearance based on substantial equivalence, not performance testing.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of this is mentioned. The clearance is based on the device's design, materials, and intended use being similar to already marketed devices. The document does not describe a clinical study in the way you've outlined.

Information that is available in the provided text:

• Device Name: I.T.S. Fibula Plate PROlock with Angular Stability
• Intended Use/Indications for Use: Titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula, including metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions, corrective osteotomy, and open and closed fractures. Not intended for spinal use.
• Materials: Plate from CP Titanium (ASTM F 67-00), screws from 6-4 Alloyed Titanium (ASTM F 136-02).
• Regulatory Pathway: 510(k) premarket notification.
• Substantially Equivalent Devices (Predicates): Synthes Semi-Tubular Plate, Synthes Small Fragment System, Synthes 4.5mm LCP Straight Reconstruction Plates, Synthes LCP Distal Tibia Plates, Synthes One-Third Tubular DCL Plate, Synthes Curved Reconstruction Plate, Synthes Medial Distal Tibia Plates, Zimmer Periarticular Plating System, Acumed Lower Extremity Congruent Plate System.

In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a report on a study demonstrating performance against acceptance criteria.

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The I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.

The I.T.S. Pilonplate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 4.5mm Cortical screws of various lengths are self-tapping and secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a medical device, the "Pilonplate with Angular Stability," and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence to previously marketed devices rather than presenting performance study results against specific criteria.

Therefore, I cannot populate the requested table and answer questions 2 through 9 based solely on the provided text. The document confirms:

• Device Name: Pilonplate with Angular Stability
• Intended Use: Fixation of complex intra- and extra-articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
• Substantial Equivalence: The basis of substantial equivalence is to Synthes, DePuy/ACE, Link America, and Zimmer bone plate systems.
• Claim of Safety and Effectiveness: "The I.T.S. Pilonplate with Angular Stability is shown to be safe and effective for use in fracture fixation of the distal tibia in the leg." However, no study data or acceptance criteria are presented to support this claim in this document.

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